Predictive Value of Periodic Repolarization Dynamics in P... | NCT02128477

Studies
Predictive Value of Periodic Repolarization Dynamics in Post-Infarction Patients

NCT02128477

Sponsor

Thebiosignals.com

Status

Completed

Last Update Posted

Jan 25, 2017Estimated

Enrollment

754Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 5, 2014

First Submission Date that Met QC Criteria

Apr 29, 2014

First Posted Date

May 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2017

Last Update Posted Date

Jan 25, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac patients. This study thoughts to prospectively validate the prognostic value of PRD in post-infarction patients.

Detailed Description

Periodic repolarization dynamics (PRD) reflect periodic changes of repolarization instability located in the low-frequency spectral range. Level of PRD can be assessed using a high resolution surface ECG recorded in the 12-leads of Frank leads configuration during resting conditions.

Increased levels of PRD have been associated with sympathetic overactivity and increased risk of mortality in survivors of acute myocardial infarction and patients undergoing a clinically indicated exercise test.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

754Actual

Measure	Description	Time Frame
Number of total deaths		24 months

Measure	Description	Time Frame
Number of cardiovascular deaths		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

previous myocardial infarction >4 weeks
age >18 years

Exclusion Criteria:

life expectancy < 1 year due to non-cardiac causes
unable to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

myocardial infarction

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eberhard-Karls-University Tuebingen		Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided